Moderna asks the FDA to authorize the Covid-19 vaccine for young children

Interviewed Tuesday by Sen. Patty Murray (D-Wash.), the FDA’s top vaccine regulator, Peter Marks, told lawmakers the agency plans to release a tentative schedule next week outlining when it plans to hold outside vaccine advisory committee meetings. vaccines for young children — a move that could offer more specific insight into when the agency plans to allow shots.

“Remember, we can’t actually complete our reviews until we have complete applications from the FDA,” Marks told the Senate Aid Committee. “We will proceed with all due speed, once we have full applications, some of them are complicated because they cover relatively larger sections of the pediatric population than others,” he added.

Moderna should soon also apply for permission for children aged 6 to 11 and file an update to its emergency use authorization for adolescents 12 to 17, two people with knowledge of the case have said, although it is unclear when these will be officially filed. Currently, the only Covid-19 vaccine available for children ages 5 to 11 is made by Pfizer and BioNTech.

The filing is likely to increase pressure on the FDA over its vaccine licensing timeline, after POLITICO reported last week that the agency had considered withholding a verdict until pharmaceutical company Pfizer seeks approval. authorization of a competing vaccine.

“We recognize that parents are eager to get their young children vaccinated against Covid-19,” an agency spokesperson told POLITICO on Thursday. “While the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request it receives as quickly as possible using a science-based approach.”

Some federal regulators have argued privately that authorizing competing vaccines at the same time would make it easier for the agency to roll them out to the public and reduce the risk of confusion. Unlike Moderna, Pfizer’s vaccine is a three-shot regimen.

But it would also likely mean waiting until June, lengthening the wait for a first Covid vaccine for millions of children and triggering backlash from parent groups and lawmakers.

“Many families with young children are reluctant to resume normal activities until the vaccine is available for their children,” Colorado Governor Jared Polis said in an interview. “You just have to present the facts to the parents and let them make that decision.”

The criticism sparked a behind-the-scenes scramble to deal with the fallout, two people familiar with the dynamics said, with health officials debating exactly how to proceed once Moderna’s full brief was submitted in early May.

“Let me be very clear, being thorough absolutely does not mean that we are delaying the review of these vaccines,” Marks said in a statement. video released by the FDA Tuesday, emphasizing the importance of ensuring parents trust all licensed vaccines. “We will act on every opportunity without sacrificing our standards to complete our assessments.”

The White House, for its part, has made it clear that the decision rests solely with the FDA, the people said. Over the past week, some officials have even gone out of their way not to discuss vaccines with FDA regulators for fear of being accused of political interference.

The application is based on evidence generated by a clinical trial involving approximately 6,700 children and seeks authorization to use the vaccine for children 6 months to under 2 years old and 2 years to under 6 years old.. In March, Moderna reported that two quarter doses of its Covid-19 vaccine produced an immune response in children 6 and under on par with the immune response of young adults who had received two full doses of the vaccine. Real-world evidence collected during Omicron showed that the vaccine reduced symptomatic cases of Covid-19 by 43.7% in children aged 6-24 months; that figure was 51% when the company only used data from PCR tests. For children aged 2 to 6, these figures were 35.7% and 37%, respectively. These levels of protection were comparable to adult protection at the time.

Children who received the vaccine experienced mild side effects, and no child in the trial developed serious Covid-19.

The FDA initially told vaccine makers that their products were expected to reduce symptomatic Covid cases in adults by 50%. For children or other groups that are more difficult to study in large numbers, the agency issued guidelines that it would allow manufacturers to use a metric called immunobridging, which compares the immune response generated by vaccines.